Catheter assembly/package utilizing a hydrating/hydrogel sleeve and method of making and using the same

ABSTRACT

A catheter assembly ( 11 ) includes an elongate member ( 14 ) having a proximal end ( 18 ) and a distal end ( 19 ). The distal end ( 19 ) has at least one drainage opening ( 15 ). A fluid containing member ( 20 ) is arranged on the elongate member ( 14 ). A container ( 12 ) contains the elongate member ( 14 ) and the fluid containing member ( 20 ). A method of using the catheter assembly ( 11 ) includes inserting a catheter ( 14 ) into a user&#39;s body and draining a fluid from the user&#39;s body.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a U.S. national stage application under 35 USC § 371of International Application No. PCT/US2010/061597, filed Dec. 21, 2010,claiming priority to U.S. Provisional Patent Application No. 61/289,849,filed Dec. 23, 2009, each of which is incorporated by reference in itsentirety into this application.

BACKGROUND OF THE INVENTION

Intermittent catheterization is an aspirationally sterile process ofdraining urine from the bladder when normal draining is impossible ordifficult. Proper intermittent catheter use reduces the risk of urinarytract infections and kidney damage. Intermittent catheters come in manydifferent sizes and lengths to fit the body. Some catheters are alsoavailable pre-lubricated. Of these, some catheters require their coatingbe hydrated before insertion. Other catheters have pre-hydratedlubricious coatings for immediate insertion upon opening the package.

Intermittent catheterization is generally performed a minimum of fourtimes a day by the patient or a care giver. The genital area near theurethral opening is wiped with an antiseptic agent, such as iodine. Alubricant may then be used to facilitate the entry of the catheter intothe urethra. A topical local anesthetic may also be applied to numb theurethral opening during the procedure. One end of the catheter is placedin a container, and the other end is inserted into and guided up theurethra and into the bladder until urine flow begins.

When urine flow stops, the catheter may be re-positioned, moved orrotated. The patient may also be made to change positions to ensure thatall urine has emptied from the bladder. The catheter may then bewithdrawn. Improper cleaning of re-used catheters can contribute to thedevelopment of urinary tract infections (UTI). Patients are encouragedto only use a new catheter for each catheterization.

Intermittent catheters are generally catheters or tubes having arounded, atraumatic distal tip that is inserted into the bladder of apatient. A molded funnel is typically connected to a distal end thatremains outside the body of the patient or user. The distal tip mayinclude slots or openings on the shaft to facilitate drainage of urinetherefrom once the tip is positioned inside the bladder.

Hydrophilic-coated intermittent catheters are intermittent cathetershaving a highly lubricious coating on an outer surface thereof, whichare either packaged with fluid or otherwise brought into contact withfluid in order to provide a catheter with a slippery outer surface tofacilitate insertion into the patient or user.

Existing hydrophilic-coated intermittent catheters fall into three broadcategories. In a first type, the catheter is packaged in a dryenvironment, but it contains a hydrophilic coating that requires awetting fluid in order to become hydrated and lubricious. The wettingfluid is obtained from an external source by the user (e.g., sink,bottled water, etc.), and the catheter is positioned within the wettingfluid for a period of time to become hydrated. Use of this first type ofintermittent catheter may prove difficult where no clean water orwetting fluid is readily available. Moreover, catheter sterility may becompromised due to the user's handling of the catheter when wettingfluid is applied.

A second type of hydrophilic-coated intermittent catheter is alsopackaged in a dry environment and contains a lubricious coating.However, the wetting fluid is positioned in a pouch or container withinthe catheter package itself. To hydrate the catheter, the pouch orcontainer is opened when the user is ready for insertion. Suitableexamples of such catheters are disclosed in U.S. Pat. Nos. 7,087,048 and6,634,498 (the disclosures of which are incorporated herein by referencein their entireties). As with the first type, this second type may bedisadvantageous because the catheter must be exposed to the wettingfluid for a period of time before insertion to ensure hydration of thelubricious coating. The sterility of the catheter can also becompromised during insertion. This concern, however, is no differentthan a pre-wetted catheter because package remains sealed duringhydration.

A third type of pre-wetted intermittent catheter is packaged in a wetenvironment. That is, the catheter is exposed to a wetting fluid withinthe catheter package, thus hydrating the coating. Suitable examples ofsuch catheters are disclosed in U.S. Pat. Nos. 7,380,658, 6,848,574 and6,059,107 (the disclosures of which are incorporated herein by referencein their entireties). However, the user may have difficulty handling thecatheter due to its slippery surface, and excessive or imprecisehandling may result in contamination of the catheter by the user. Thiscould then expose the user to a urinary tract infection.

An example of the third type is shown in FIGS. 1 and 2 of the instantapplication. As can be seen in these drawings, the catheter assemblyutilizes a catheter 1 arranged in a package 2 made of two sheets 2 a and2 b which can be separated from each other (see FIG. 2) so as to allowaccess to the catheter 1. The catheter 1 is arranged in a space 3arranged within the package 2 along with a hydrating fluid. In this way,the coating C arranged on a tube portion 4 of the catheter 1 ismaintained in a hydrated or pre-wetted state. The catheter 1 includes afunnel 7 arranged on a proximal end 8 and a closed and rounded tip atthe distal end 9. One or more drainage eyelets 5 are arranged in an areaof the distal end 9. When user desires to use the catheter assemblyshown in FIG. 1, the user need only open the package 2 (see FIG. 2),remove the catheter 1 from the package 2 which is already pre-wetted,and insert the distal end 9 into the bladder.

Existing intermittent catheters may also drain urine into a bag.Following bladder drainage into the bag, the bag may be emptied byinverting and tearing a notch. Urine is then drained into a receptaclethrough the tear. That process can be slow, messy, and subject to urinespills.

Non-intermittent catheterization, which is used in a hospital or nursinghome setting, uses the same basic technique for insertion of the urinarytract catheter. The catheter is inserted by a nurse or other health careprofessional, and, it remains in the patient until bladder function canbe maintained independently. When the catheter is removed, patientsexperience a pulling sensation and may feel some minor discomfort. Ifthe catheter is required for an extended period of time, a long-term,indwelling catheter, such as a Foley catheter, is used. To preventinfection, it should be regularly exchanged for a new catheter.

Proper catheter use can also often be determined by the length of timethat the process is necessary: long-term (often called indwelling) orshort-term use. In some situations, incontinent patients arecatheterized to reduce their cost of care. A condom catheter, which fitson the outside of the penis using adhesive, can be used for short-termcatheterization in males. However, long-term catheterization is notrecommended because chronic use carries a significant risk of urinarytract infection. This risk should only be considered as a last resortfor the management of incontinence where other measures have provedunsuccessful and where there is significant risk to the skin.

A catheter that is left in place for a period of time may be attached toa drainage bag to collect the urine. There are two types of drainagebags. One is a leg bag being a smaller drainage device that attaches byelastic bands to the leg. A leg bag is usually worn during the day, asit fits discreetly under pants or skirts, and is easily emptied into atoilet. The second type of drainage bag is a larger device called a downdrain that may be used during the night. This device is usually hung onthe patient's bed or placed on the floor nearby.

During long-term use, the catheter may be left in place the entireduration, or a patient may be instructed on an intermittentself-catheterization procedure for placing a catheter just long enoughto empty the bladder and then removing it. Patients undergoing majorsurgery are often catheterized and may remain so for long durations.Long-term catheterization can expose patients to an increased risk ofinfection. Long-term catheterization as a remedy for incontinence is notappropriate, as the risks outweigh the benefits.

In males, for example, the catheter tube is inserted into the urinarytract through the penis. Insertion in males can sometimes be difficultbecause of the abrupt angle in the male's urethra. An external devicesuch as a condom catheter can also be used. In females, the catheter isinserted into the urethral meatus, after a cleansing. The procedure canbe complicated in females due to varying layouts of the genitalia (dueto age, obesity, childbirth, or other factors), but a good clinicianshould rely on anatomical landmarks and patience when dealing with suchpatients.

Common indications to catheterize a patient include acute or chronicurinary retention (which can damage the kidneys), orthopedic proceduresthat may limit a patient's movement, the need for accurate monitoring ofinput and output (such as in an ICU), benign prostatic hyperplasia,incontinence, and the effects of various surgical interventionsinvolving the bladder and prostate.

For some patients the insertion and removal of a catheter can causeexcruciating pain, so a topical anesthetic can be used for patients ofboth sexes. Catheterization should be performed as a sterile medicalprocedure and should only be done by trained, qualified personnel, usingequipment designed for this purpose. However, in the case ofintermittent self catheterization, the patient can perform the procedurehis/her self. If correct technique is not used, trauma may be caused tothe urethra or prostate (male). A urinary tract infection orparaphimosis may also occur (male uncircumcised patient).

Particular complications of catheter use may include: urinary tract orkidney infections, blood infections (sepsis), urethral injury, skinbreakdown, bladder stones, and blood in the urine (hematuria). Aftermany years of catheter use, bladder cancer may also develop. In usingindwelling (long-term) catheters, it is particularly very important totake everyday care of the catheter and the drainage bag.

Catheters come in a large variety of sizes, materials (latex, silicone,PVC, or Teflon-coated), and types (for example, straight or coude tipcatheter). In the case of internal catheters (those inserted into theurethra), the smallest size is usually recommended, although a largersize is sometimes needed to control leakage of urine around thecatheter. A large size can also become necessary when the urine isthick, bloody or contains large amounts of sediment. Larger internalcatheters, however, are more likely to cause damage to the urethra. Somepeople develop allergies or sensitivities to latex after long-term latexcatheter use or prior latex exposure. In such cases, catheters made ofmaterials other than natural rubber latex should be used. Silver coatedurinary catheters may also be used to reduce infections.

Catheter diameters are sized by the French catheter scale (F or Fr). Themost common sizes are 10 Fr to 28 Fr. The clinician selects a size smallenough to allow free flow of urine, but large enough to control leakageof urine around the catheter. A larger size can become necessary whenthe urine is thick, bloody or contains large amounts of sediment. Largercatheters, however, are more likely to cause damage to the urethra.(Jeffrey A N et al., Surgery: Basic Science and Clinical EvidenceSpringer, 2nd ed., 2008, p. 281).

Finally, it is noted that existing intermittent catheters typically havetwo staggered or opposed drainage eyelets or openings which are locatedon a distal end of the catheter, i.e., near the inserting tip. Theseopenings allow the catheter to drain urine from the bladder.

SUMMARY OF THE INVENTION

The present invention is directed to easy-to-use urinary catheterassemblies that eliminate or minimize some of the shortcomings of priorart devices. The catheter can be a single-use catheter and/or may bepackaged as a single-use device. Non-limiting embodiments of theinvention include one or more features described herein and/or shown inthe drawings in combination with one of more prior art featuresdiscussed above.

Non-limiting embodiments of the invention provide for an improvedpre-wetted catheter which maintains a coating of the catheter tube in ahydrated state using a hydrating sleeve.

Non-limiting embodiments of the invention also provide for improvedpre-wetted catheter whose package can be opened without any significantspilling of moisture or fluid from the package.

Non-limiting embodiments of the invention also provide for improvedpre-wetted catheter having a sleeve which contains all or substantiallyall of the hydrating fluid.

Non-limiting embodiments of the invention also provide for a catheterassembly comprising an elongate member having a proximal end and adistal end. The distal end has at least one drainage opening. A fluidcontaining member is arranged on the elongate member. A containercontains the elongate member and the fluid containing member.

The fluid containing member may be a hydrogel sleeve. The fluidcontaining member may have a wall thickness that is ⅛ inch or greater.The fluid containing member may be generally cylindrical. The fluidcontaining member may be structured and arranged to maintain a coatingof the elongate member in a hydrated condition. The containing membermay be a tube having an inside diameter sized to receive therein theelongate member. The fluid containing member may comprise an extrudedpolyurethane tube. The fluid containing member may comprise apolyurethane hydrogel type material. A non-limiting example of the fluidcontaining member includes D6/40 (AdvanSource Biomaterials) which is apolyether polyurethane-urea. The fluid containing member may comprise ahydrophilic polymer.

By way of non-limiting examples, the hydrophilic polymer of the fluidcontaining member may comprise at least one of; polyethylene oxide,polyethylene glycol, polypropylene glycol, poly vinyl alcohol, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxyl ethyl methacrylate,polyacrylic acid, polyacrylamide, and collagen. The fluid containingmember may comprise a material which swells when exposed to a fluid andwhich absorbs and retains fluid in a wall between an inner diameter andan outer diameter. The fluid containing member may be structured andarranged to swell when exposed to a fluid. The fluid containing membermay be structured and arranged to swell when exposed to water. The fluidcontaining member may be structured and arranged to absorb about 90% ormore of its weight in fluid. The fluid containing member may bestructured and arranged to absorb about 90% or more of its weight inwater. The fluid containing member comprises a hydrated polyurethanetube.

The container may be a fluid impermeable package and substantially ornearly all fluid contained in the container may be disposed in the fluidcontaining member.

The elongate member may comprise one of: a hydratable coating arrangedat least on an outer surface of the distal end thereof; a lubriciouscoating arranged at least on an outer surface of the distal end thereof;and a hydrophilic biocompatible coating arranged at least on an outersurface of the distal end.

The catheter assembly may be an intermittent catheter assembly. Thefluid containing member may be the only device containing fluid in thecontainer. The fluid containing member may be non-removably coupled tothe container. The elongate member may be removable from the containerwithout fluid leaking out of the container. The elongate member may beremovable from the container while the fluid containing member isretained within the container. The elongate member may comprise aproximal end which is not wetted and/or covered by the fluid containingmember. The elongate member may be removable from the container with thefluid containing member.

The fluid containing member may comprise a gripping end which does notcontain fluid and/or which allows a user to grip the fluid containingmember without the user's fingers becoming wetted by fluid.

The container may comprise a first compartment containing the elongatemember and a second compartment containing the fluid containing member.The elongate member may be removable from the first compartment andinsertable into the second compartment. The elongate member may beremovable from the first compartment and insertable into the fluidcontaining member of the second compartment. A first removable cover mayallow the user to access and remove the elongate member from the firstcompartment and a second removable cover may allow the user to insertthe elongate member into the second compartment. The first compartmentand the second compartment may comprise separate fluid impermeablecompartments.

The container may comprise an outer member which substantially enclosesthe elongate member and completely encloses the fluid containing member.The fluid containing member may be non-removably coupled to the outermember. The fluid containing member may be non-removably coupled to aninside diameter of the outer member. The outer member may comprise afirst portion that surrounds a proximal portion of the elongate memberand a second portion that surrounds the fluid containing member. Theouter member may comprise a first portion that surrounds a funnelportion of the elongate member and a second portion that surrounds thefluid containing member and a coated tube portion of the elongatemember. The outer member may have a length that is substantially equalto a length of the elongate member and the fluid containing member mayhave a length that is substantially equal to the coated tube portion ofthe elongate member.

The container may comprise an outer tubular member which completelyencloses the elongate member and completely encloses the fluidcontaining member. The fluid containing member may be arranged withinanother container arranged within the outer tubular member. The othercontainer containing the fluid containing member may be removable fromthe outer tubular member. The other container containing the fluidcontaining member may be non-removable from the outer tubular member.The outer tubular member may comprise a removable cover.

The container may enclose the elongate member and the fluid containingmember while axially separated from each other. The container maycontain a single compartment which encloses the elongate member and thefluid containing member while axially separated from each other. Thecontainer may comprise a single flexible compartment which encloses theelongate member and the fluid containing member while axially separatedfrom each other and is configured to allow the user to position theelongate member into the fluid containing member while the elongatemember and the fluid containing member remain enclosed within the singleflexible compartment.

Non-limiting embodiments of the invention also provide for a method ofinserting the catheter assembly of any one of the types described above,wherein the method comprises removing the elongate member from the fluidcontaining member and inserting the elongate member into a user's body.The method may further comprise draining fluid or urine from the user'sbody.

Non-limiting embodiments of the invention also provide for a catheterassembly comprising a catheter having a proximal end, a distal end, anda tubular portion arranged therebetween, the distal end having at leastone drainage opening, a fluid containing sleeve arranged on the tubularportion and maintaining a coating of the tubular portion in a hydratedstate, and a container containing therein the catheter and the fluidcontaining sleeve. Substantially or nearly all fluid contained in thecontainer is disposed in the fluid containing sleeve.

At least one of the following may be utilized: the fluid containingsleeve is a hydrogel sleeve; the fluid containing sleeve has a wallthickness that is ⅛ inch or greater when fully hydrated; the fluidcontaining sleeve comprises an extruded polyurethane tube; the fluidcontaining sleeve comprises D6/40 polyurethane; the fluid containingsleeve comprises a hydrophilic polymer and the hydrophilic polymercomprises at least one of: polyethylene oxide; poly vinyl alcohol;carboxy methyl cellulose; hydroxyl ethyl methacrylate; acrylic polymers;and collagen; the fluid containing sleeve comprises a material whichswells when exposed to a fluid and which absorbs and retains fluid in awall between an inner diameter and an outer diameter; the fluidcontaining sleeve is structured and arranged to swell when exposed to afluid; the fluid containing sleeve is structured and arranged to swellwhen exposed to water; the fluid containing sleeve is structured andarranged to absorb about 90% of its weight in fluid; the fluidcontaining member is structured and arranged to absorb about 90% of itsweight in water; and the fluid containing member comprises a hydratedpolyurethane tube.

Non-limiting embodiments of the invention also provide for a catheterassembly comprising a catheter having a funnel, a tubular portion and atleast one drainage opening and a fluid containing sleeve structured andarranged to swell when exposed to a fluid. The fluid containing sleeveis arranged on the tubular portion and maintaining a coating of thetubular portion in a hydrated state. A container contains therein thecatheter and the fluid containing sleeve. Substantially or nearly allfluid contained in the container is disposed in the fluid containingsleeve.

BRIEF DESCRIPTION OF DRAWINGS OF THE EXEMPLARY EMBODIMENTS

FIG. 1 shows a pre-wetted catheter assembly package in accordance withthe prior art.

FIG. 2 shows the catheter assembly of FIG. 1 being opened for use byseparating two portions which form the package.

FIG. 3 shows a pre-wetted catheter assembly package in accordance withone non-limiting embodiment of the invention.

FIG. 4 shows a side cross-sectional view of the catheter and hydratingsleeve used in the assembly package of FIG. 3.

FIG. 5 shows a side cross-sectional view of the hydrating sleeve used inthe assembly package of FIG. 3.

FIG. 6 shows an enlarged end view of the hydrating sleeve shown in FIG.5.

FIG. 7 shows a side cross-sectional view of the catheter used in theassembly package of FIG. 3.

FIG. 8 shows a pre-wetted catheter assembly package in accordance withanother non-limiting embodiment of the invention.

FIG. 9 shows a pre-wetted catheter assembly package in accordance withstill another non-limiting embodiment of the invention.

FIG. 10 shows a pre-wetted catheter assembly package in accordance withstill another non-limiting embodiment of the invention.

FIG. 11 shows a pre-wetted catheter assembly package in accordance withstill another non-limiting embodiment of the invention.

FIG. 12 shows a pre-wetted catheter assembly package in accordance withstill another non-limiting embodiment of the invention.

FIGS. 13 and 14 show a pre-wetted catheter assembly package inaccordance with still another non-limiting embodiment of the invention.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

The following description should be read with reference to the drawings,in which like elements in different drawings are identically numbered.The drawings, which are not necessarily to scale, depict selectedembodiments and are not intended to limit the scope of the invention.The detailed description illustrates by way of example, not by way oflimitation, the principles of the invention. This description willenable one skilled in the art to make and use the invention, anddescribes several embodiments, adaptations, variations, alternatives anduses of the invention, including what is presently believed to be thebest mode of carrying out the invention.

As used herein, the reference terms “proximal” and “distal” (proximalbeing closer than distal) refer to proximity with respect to a healthcare professional catheterizing a patient. For example, the region orsection of the catheter apparatus that is closest to the health careprofessional during catheterization is referred to herein as “proximal,”while a region or section of the catheter apparatus closest to thepatient's bladder is referred to as “distal.” In the case of aself-catheterizing patient, proximal refers to a point external to thepatient's body, and distal refers to a point within the patient's body(i.e., the bladder).

The catheter assemblies as described herein are discussed in the contextof a urinary catheter for insertion into a bladder for drainage of urinetherefrom. The instant catheter assemblies, however, may also be usedfor other applications not specifically mentioned herein. As such, theinstant invention is not limited to urinary catheter applications.

FIGS. 3-7 show a non-limiting embodiment of a pre-wetted urinarycatheter assembly package of the present invention. FIG. 3 shows thecatheter assembly package in a storage position and/or prior to useconfiguration whereas FIG. 7 shows the catheter in a ready to useconfiguration.

The assembly package 10 shown in FIG. 3 includes a catheter 11 arrangedwithin a container 12 which can be in the form of a package such as thetype shown in FIG. 2. The catheter assembly 11 includes a catheterhaving an insertable elongate tube portion 14, one or more drainageeyelets 15, a funnel 17, a proximal end 18, and a distal end 19. A fluidcontaining sleeve 20 is arranged in the package 12 and is positionedover a substantial portion of the tube 14. The sleeve 20 contains all ornearly all of the fluid that is arranged in the container 12 and is indirect contact with a coating of the tube 14. The funnel 17 remains in adry state in a non-fluid containing space 13 of the package 12. Thus,only the portion of the catheter in contact with the sleeve 20, i.e.,the tube 14, is wetted or maintained in a pre-wetted state. Inembodiments, the sleeve 20 is non-removably connected to the package 12so that when the user tears or splits open the end of the package 12defining space 13, the user can grip the funnel 17 and slide thecatheter out of the package 12 and sleeve 20 (which remains in thepackage 12). Since all or nearly all of the fluid which hydrates thecoating of the tube 14 is disposed in the sleeve 20, removing thecatheter will not cause any fluid to spill out of the package 12 whenopened. Furthermore, if the sleeve 20 remains in the package 12, theuser need not come into contact with the fluid. Once the catheter isremoved from the package 12, it can be inserted into the user's bodywhile the user grips the funnel 17. As is the case with conventionalcatheters, the coating of the tube 14 is, in embodiments, a lubriciouscoating to facilitate insertion of the catheter into the user's body.

According to another embodiment, the distal end 19 is urged throughdistal end of the container 12 and is installed into the urethra. Theproximal end of the container 12 may be opened before or after urethrainsertion. This method minimizes exposure of the tube 14 to anon-sterile environment and thus minimizes risk of infection.

In order to form the assembly package of FIG. 3, in embodiments, acatheter of the type shown in FIG. 7 can be inserted into a fluidcontaining sleeve 20 shown in FIG. 5 so as to form the sub-assemblyshown in FIG. 4. However, prior to insertion into the sleeve 20, thesleeve 20 can be exposed to or immersed in a fluid such as water. Sincethe sleeve 20 is made of a material that can absorb fluid and expand,this causes the sleeve 20 to swell until it reaches a wall thickness T(see FIG. 6). In this swollen state, the sleeve 20 retains the fluidbetween an inside diameter 20 b and an outside diameter 20 a. Once thesleeve 20 is slid onto the catheter as shown in FIG. 4, it can maintainthe coating of the tube 14 is a hydrated state. The sub-assembly shownin FIG. 4 can then be slid into the package 12. Furthermore, since thepackage 12 is fluid impermeable, it ensures that the fluid in the sleeve20 cannot escape the package 12 or be contaminated with substancesoutside the package 12. In embodiments, the inside diameter 20 b isfluid permeable and wets and hydrates the coating of the tube 14 whencontacting the tube 14. In embodiments, the outside diameter 20 a isalso fluid permeable and slightly wets the package 12 when contactingthe same. However, unlike the coating of the tube 14, the package 12does not absorb the fluid. In embodiments, the outside diameter 20 a canalternatively be made fluid impermeable so as not to wet the package 12when contacting the same.

In order to form the assembly package of FIG. 3, in other embodiments, acatheter of the type shown in FIG. 7 can be inserted into a fluidcontaining sleeve 20 shown in FIG. 5 after the sleeve 20 is alreadyinstalled in the package 12. However, prior to insertion into thepackage 12, the sleeve 20 can be exposed to or immersed in a fluid suchas water. Since the sleeve 20 is made of a material that can absorbfluid and expand, this causes the sleeve 20 to swell until it reaches awall thickness T (see FIG. 6). In this swollen state, the sleeve 20retains the fluid between an inside diameter 20 b and an outsidediameter 20 a. Once the catheter is slid into the sleeve 20 disposed inthe package 12, it can maintain the coating of the tube 14 is a hydratedstate.

In order to form the assembly package of FIG. 3, in still otherembodiments, a catheter of the type shown in FIG. 7 can be inserted intoa fluid containing sleeve 20 shown in FIG. 5 after the sleeve 20 isalready installed in the package 12. After insertion into the package12, the sleeve 20 and package 12 can be exposed to or immersed in afluid such as water. Since the sleeve 20 is made of a material that canabsorb fluid and expand (even while the package 12 cannot absorb fluid),this causes the sleeve 20 to swell until it reaches a wall thickness T(see FIG. 6). In this swollen state, the sleeve 20 retains the fluidbetween an inside diameter 20 b and an outside diameter 20 a. Once thecatheter is slid into the sleeve 20 disposed in the package 12, it canmaintain the coating of the tube 14 is a hydrated state.

The elongate member 14 can have any size and shape typically utilized inconventional catheters such as generally cylindrical and defines aninterior lumen or space which allows fluid to pass and/or drain through.The proximal end 18 includes a funnel which can be of any type that istypically utilized in catheters. The funnel can be connected to any typefluid collection system or bag that is typically utilized in catheters.By way of non-limiting example, the funnel can be a rubber or plasticdrainage funnel disposed and adhered to the proximal end of the member14. A disposable bag (not shown) may be disposed on and/or coupled tothe drainage funnel to collect the patient's urine. The distal end 19 ofmember 14 also includes a tip. The tip is arranged on a forward mostportion of the distal end and defines the insertion end of the catheter.The elongate member 14 also preferably contains a biocompatible,hydrophillic, antimicrobial and/or lubricious coating on its outersurface which is hydrated by the sleeve 20. The coating may also haveantimicrobial properties or contain an antimicrobial agent.

FIG. 8 shows another non-limiting embodiment of a pre-wetted urinarycatheter of the present invention. In FIG. 8, the catheter assemblypackage is in a storage position and/or prior to use configuration.

The assembly package 110 shown in FIG. 8 includes a catheter 111arranged within a container 112 which can be in the form of a packagesuch as the type shown in FIG. 2 and having package sheets 112 a and 112b. The catheter assembly 111 includes a catheter having an insertableelongate tube portion 114, one or more drainage eyelets 115, a funnel117 arranged on a proximal end, and a distal end. A fluid containingsleeve 120 is arranged in the package 112 and is positioned over asubstantial portion of the tube 114. The sleeve 120 utilizes a grippingportion 121 which allows the user to remove the sleeve 120 from thecatheter. As with the previous embodiment, the sleeve 120 contains allor nearly all of the fluid that is arranged in the container 112 and isin direct contact with a coating of the tube 114. The funnel 117 andgripping portion 121 remain in a dry state in a non-fluid containingspace 113 of the package 112. Thus, only the portion of the catheter incontact with the sleeve 120, i.e., the tube 114, is wetted or maintainedin a pre-wetted state. In embodiments, the sleeve 120 is removable fromthe package 112 with the catheter as assembly 111 when the user tears orsplits open the end of the package 112. Once removed from the package112, the user can grip the funnel 117 with one hand and the grippingportion 121 with the other hand, and then slide the catheter out of thesleeve 120 and/or slide the sleeve 120 off of the catheter. Since all ornearly all of the fluid which hydrates the coating of the tube 114 isdisposed in the sleeve 120, removing the catheter assembly 111 from thepackage 112 will not cause any fluid to spill out of the package 112when opened. Furthermore, if the sleeve 120 is gripped by the end 121and placed back into the package 112, the user need not come intocontact with the fluid. Once the catheter is removed from the package112, it can be inserted into the user's body while the user grips thefunnel 117. As is the case with conventional catheters, the coating ofthe tube 114 is, in embodiments, a lubricious coating to facilitateinsertion of the catheter into the user's body.

According to another embodiment, the tip of the tube 114 can be advancedthrough the closed end of the member 121 during insertion into theurethra. One way to provide such an arrangement is to form or providethe member 121 with a scored or weakened area, e.g., a circumferentialscored area, which can break or separate when the tip of the tube 114 isforced against the member 121.

In order to form the assembly package of FIG. 8, in embodiments, acatheter of the type shown in FIG. 7 can be inserted into a fluidcontaining sleeve 120 shown in FIG. 8. However, prior to insertion intothe sleeve 120, the sleeve 120 can be exposed to or immersed in a fluidsuch as water. Since the sleeve 120 is made of a material that canabsorb fluid and expand, this causes the sleeve 120 to swell until itreaches a wall thickness T (similar to that shown in FIG. 6). In thisswollen state, the sleeve 120 retains the fluid between an insidediameter and an outside diameter. Once the sleeve 120 is slid onto thecatheter as shown in FIG. 8, it can maintain the coating of the tube 114is a hydrated state. This sub-assembly 111 can then be slid into thepackage 112. Furthermore, since the package 112 is fluid impermeable, itensures that the fluid in the sleeve 120 cannot escape the package 112or be contaminated with substances outside the package 112. Inembodiments, the inside diameter of the sleeve 120 is fluid permeableand wets and hydrates the coating of the tube 114 when contacting thetube 114. In embodiments, the outside diameter of the sleeve 120 is alsofluid permeable and slightly wets the package 112 when contacting thesame. However, unlike the coating of the tube 114, the package 112 doesnot absorb the fluid. In embodiments, the outside diameter canalternatively be made fluid impermeable so as not to wet the package 112when contacting the same.

FIG. 9 shows another non-limiting embodiment of a pre-wetted urinarycatheter of the present invention. In FIG. 9, the catheter assemblypackage is in a storage position and/or prior to use configuration.

The assembly package 210 shown in FIG. 9 includes a catheter arrangedwithin a first compartment 213 a of a container 212 which can be in theform of a package such as the type shown in FIG. 2. A fluid containingsleeve 220 is arranged within a second compartment 213 b of thecontainer 212. The catheter has an insertable elongate tube portion 214,one or more drainage eyelets, a funnel 217 arranged on a proximal end,and a distal end. The fluid containing sleeve 220 is sized to bepositioned over a substantial portion of the tube 214. When the userdesires to use the catheter, the user removes sealing covers 222 and223, then removes the catheter from the compartment 213 a. The user theninserts the catheter into the compartment 213 b making sure to insertthe tube 214 into the lumen of the sleeve 220. After fully inserting thetube 214 into the sleeve 220 and waiting for a short predetermined timeperiod, i.e., a few seconds to a few minutes (a time period sufficientto allow the coating of the tube 214 to become sufficiently hydratedand/or pre-wetted), the use can remove the catheter from the compartment213 b (while the sleeve 220 remains in the compartment 213 b or on thecatheter) and then insert the same into the user's body. As with theprevious embodiment, the sleeve 220 contains all or nearly all of thefluid that is arranged in the container 212 and can be placed in directcontact with a coating of the tube 214. The funnel 217 remains in a drystate in a non-fluid containing space 213 a of the package 212. Thus,only the portion of the catheter in contact with the sleeve 220, i.e.,the tube 214, is wetted or maintained in a pre-wetted state. Inembodiments, the sleeve 220 is not removable from the package 212 withthe catheter. Once removed from the package 212, the user can grip thefunnel 217 with one hand and the package 212 with the other hand, andthen slide the catheter out of the compartment 213 a and then into thesleeve 220. Since all or nearly all of the fluid which hydrates thecoating of the tube 214 is disposed in the sleeve 220, removing thecatheter assembly from the package 212 will not cause any fluid to spillout of the package 212 when opened. Furthermore, if the sleeve 220 isgripped from outside the package 212 and is retained in the compartment213 b, the user need not come into contact with the fluid. Once thecatheter is removed from the package 212 and properly hydrated, it canbe inserted into the user's body while the user grips the funnel 217. Asis the case with conventional catheters, the coating of the tube 214 is,in embodiments, a lubricious coating to facilitate insertion of thecatheter into the user's body.

In order to form the assembly package of FIG. 9, in embodiments, acatheter of the type shown in FIG. 7 can be inserted into compartment213 a shown in FIG. 9 and then the cap 222 can be installed. A sleeve220 of the type shown in FIG. 5 can be inserted into compartment 213 bshown in FIG. 9 and then the cap 223 can be installed. However, prior toinsertion into the sleeve 220, the sleeve 220 can be exposed to orimmersed in a fluid such as water. Since the sleeve 220 is made of amaterial that can absorb fluid and expand, this causes the sleeve 220 toswell until it reaches a wall thickness T (similar to that shown in FIG.6). In this swollen state, the sleeve 220 retains the fluid between aninside diameter and an outside diameter. Once the catheter is slid intothe sleeve 220, it can hydrate the coating of the tube 214. Furthermore,since the package 212 is fluid impermeable, it ensures that the fluid inthe sleeve 220 cannot escape the package 212 or be contaminated withsubstances outside the package 212. In embodiments, the inside diameterof the sleeve 220 is fluid permeable and wets and hydrates the coatingof the tube 214 when contacting the tube 214. In embodiments, theoutside diameter of the sleeve 220 is also fluid permeable and slightlywets the package 212 when contacting the same. However, unlike thecoating of the tube 214, the package 212 does not absorb the fluid. Inembodiments, the outside diameter can alternatively be made fluidimpermeable so as not to wet the package 212 when contacting the same.

In embodiments, the caps 222 and 223 are optional. In embodiments, thesecan be formed by sealing the ends of the package (after inserting thecatheter members into the package). These ends can then be torn orpeeled open. Such an alternative configuration to the caps 222 and 223would likely be cheaper to manufacture.

FIG. 10 shows another non-limiting embodiment of a pre-wetted urinarycatheter assembly package of the present invention. In FIG. 10, thecatheter assembly package is in a storage position and/or prior to useconfiguration.

The assembly package 310 shown in FIG. 10 includes a catheter arrangedwithin a container which is in the form of an outer sleeve 320B and endcap 321. The catheter assembly includes a catheter having an insertableelongate tube portion 314, one or more drainage eyelets 315, a funnel317, a proximal end 318, and a distal end 319. A fluid containing sleeve320A is arranged in the package sleeve 320B and is positioned over asubstantial portion of the tube 314. The sleeve 320A contains all ornearly all of the fluid that is arranged in the container 320B and is indirect contact with a coating of the tube 314. The funnel 317 remains ina dry state in a non-fluid containing space of the package 320B. Thus,only the portion of the catheter in contact with the sleeve 320A, i.e.,the tube 314, is wetted or maintained in a pre-wetted state. Inembodiments, the sleeve 320A is non-removably connected to the outersleeve 320B. In embodiments, the user can remove the member 321 and,while griping the funnel 317 or the sleeve 320, can advance the distalend 319 into the urethra or urethral meatus. Alternatively, the user canslide off the sleeve 320A when the user can grips the funnel 317 andslides the catheter out of the package 320B (the sleeve 320A remains inthe package 320B). Since all or nearly all of the fluid which hydratesthe coating of the tube 314 is disposed in the sleeve 320A, removing thecatheter will not cause any fluid to spill out of the package 320B whenopened. Furthermore, as the sleeve 320A remains in the package 320B, theuser need not come into contact with the fluid. Once the catheter isremoved from the package 320B, it can be inserted into the user's bodywhile the user grips the funnel 317. As is the case with conventionalcatheters, the coating of the tube 314 is, in embodiments, a lubriciouscoating to facilitate insertion of the catheter into the user's body.

In order to form the assembly package of FIG. 10, in embodiments, acatheter of the type shown in FIG. 7 can be inserted into a fluidcontaining sleeve 320A shown in FIG. 5 which is arranged within an outersleeve 320B. However, prior to insertion into the sleeve 320A, thesleeve 320A can be exposed to or immersed in a fluid such as water.Since the sleeve 320A is made of a material that can absorb fluid andexpand, this causes the sleeve 320A to swell until it reaches a wallthickness T (see FIG. 6). In this swollen state, the sleeve 320A retainsthe fluid between an inside diameter and an outside diameter. Once thecatheter is slid into the sleeve 320A, it can maintain the coating ofthe tube 314 is a hydrated state. This sub-assembly can then be slidinto the sleeve package 320B. Furthermore, since the sleeve package 320Bis fluid impermeable, it ensures that the fluid in the sleeve 320Acannot escape the package 320B or be contaminated with substancesoutside the package. In embodiments, the inside diameter of the sleeve320A is fluid permeable and wets and hydrates the coating of the tube314 when contacting the tube 314. In embodiments, the outside diameterof the sleeve 320A is also fluid permeable and slightly wets the sleevepackage 320B when contacting the same. However, unlike the coating ofthe tube 314, the package 320B does not absorb the fluid. Inembodiments, the outside diameter of sleeve 320A can alternatively bemade fluid impermeable so as not to wet the package 320B when contactingthe same. Although not shown, a removable cap be arranged on the distalend of the sleeve 320B in order to prevent contact with the funnel 317and to seal off the distal end of the sleeve package 320B.

In order to form the assembly package of FIG. 10, in other embodiments,a catheter of the type shown in FIG. 10 can be inserted into a fluidcontaining sleeve 320A shown in FIG. 10 after the sleeve 320A is alreadyinstalled in the sleeve package 320B. However, prior to insertion intothe package 320B, the sleeve 320A can be exposed to or immersed in afluid such as water. Since the sleeve 320A is made of a material thatcan absorb fluid and expand, this causes the sleeve 320A to swell untilit reaches a wall thickness T (see FIG. 6). In this swollen state, thesleeve 320A retains the fluid between an inside diameter and an outsidediameter. Once the catheter is slid into the sleeve 320A disposed in thepackage 320B, it can maintain the coating of the tube 314 is a hydratedstate.

In order to form the assembly package of FIG. 10, in still otherembodiments, a catheter of the type shown in FIG. 7 can be inserted intoa fluid containing sleeve 320A shown in FIG. 5 after the sleeve 320A isalready installed in the package 320B. After insertion into the package320B, the sleeve 320A and package 320B can be exposed to or immersed ina fluid such as water. Since the sleeve 320A is made of a material thatcan absorb fluid and expand (even while the package 320B cannot absorbfluid), this causes the sleeve 320A to swell until it reaches a wallthickness T (see FIG. 6). In this swollen state, the sleeve 320A retainsthe fluid between an inside diameter and an outside diameter. Once thecatheter is slid into the sleeve 320A disposed in the package 320B, itcan maintain the coating of the tube 314 is a hydrated state.Furthermore, by allowing the sleeve 320A to expand while arranged in thesleeve package 320B, the sleeve 320A can form a frictional engagementwith the sleeve 320B and thereby prevent its removal when the catheteris slid out of the sleeve 320A.

FIG. 11 shows another non-limiting embodiment of a pre-wetted urinarycatheter assembly package of the present invention. In FIG. 11, thecatheter assembly package is in a storage position and/or prior to useconfiguration.

The assembly package 410 shown in FIG. 11 includes a catheter arrangedwithin a container which has the form of an outer sleeve 412 and end cap(the distal portion of sleeve 412 to the left of the dashed-line). Thecatheter assembly includes a catheter having an insertable elongate tubeportion 414, one or more drainage eyelets 415, a funnel 417, a proximalend, and a distal end 419. A fluid containing sleeve container 420 isarranged in the package sleeve 412 and is positioned over a shortportion of the tube 414. The sleeve container 420 includes an outercontainer 420B, a fluid containing sleeve 420A arranged in the container420B, and end seals 420 a and 420 b. The fluid containing sleeve 420Acontains all or nearly all of the fluid that is arranged in thecontainer 420 and is in direct contact with a portion of the coating ofthe tube 414. The funnel 417 and a distal portion of the tube 414remains in a dry state in a non-fluid containing space of the package412. Thus, only the portion of the catheter in contact with the sleeve420A, i.e., a portion of the tube 414, is wetted or maintained in apre-wetted state. In embodiments, the sleeve 420A is removable from thepackage 412. In this way, the user can remove the catheter and sleeve420 from the package 412 when the user grips the funnel 417 and slidesthe catheter out of the package 412. Since all or nearly all of thefluid which hydrates the coating of the tube 414 is disposed in thesleeve 420A, removing the catheter and container 420 will not cause anyfluid to spill out of the package 412 when opened. Furthermore, as thesleeve 420A remains in the container 420, the user need not come intocontact with the fluid. Once the catheter is removed from the package412 with container 420, the user can move or slide the container 420back and forth over the tube 414 in order to sufficiently hydrate thecoating of the tube 414. Once the coating is sufficiently hydrated, theuser can remove the container 420 by sliding it completely off of thedistal end 419 and place it back into the package 412. The user can thengrip the funnel 417 and insert the catheter into the user's body or, inembodiments, grip the sleeve 410 and advance the catheter 414 throughthe sleeve 410 and into the urethra. As is the case with conventionalcatheters, the coating of the tube 414 is, in embodiments, a lubriciouscoating to facilitate insertion of the catheter into the user's body.

In order to form the assembly package of FIG. 11, in embodiments, afluid containing sleeve 420A is hydrated and arranged in a container420B so as to form container 420. In this swollen state, the sleeve 420Aretains the fluid between an inside diameter and an outside diameter.The container 420 can then be slid onto a catheter. This sub-assembly isthe placed into a container package 412. Furthermore, since thecontainer 420B is fluid impermeable, it ensures that the fluid in thesleeve 420A cannot escape the container 420 or be contaminated withsubstances outside the package. In embodiments, the inside diameter ofthe sleeve 420A is fluid permeable and wets and hydrates the coating ofthe tube 414 when contacting the tube 414. In embodiments, the outsidediameter of the sleeve 420A is also fluid permeable and slightly wetsthe container body 420B when contacting the same. However, unlike thecoating of the tube 414, the container body 420B does not absorb thefluid. In embodiments, the outside diameter of sleeve 420A canalternatively be made fluid impermeable so as not to wet the containerbody 420E when contacting the same.

FIG. 12 shows another non-limiting embodiment of a pre-wetted urinarycatheter assembly package of the present invention. In FIG. 12, thecatheter assembly package is in a storage position and/or prior to useconfiguration.

The assembly package 510 shown in FIG. 12 includes a catheter arrangedwithin a container which has the form of an outer sleeve 512 a and endcap 512 b. The catheter assembly includes a catheter having aninsertable elongate tube portion 514, one or more drainage eyelets, afunnel, a proximal end, and a distal end. A fluid containing sleevecontainer 520 is arranged in the package sleeve 512 a and is positionedover a short portion of the tube 514. The sleeve container 520 includesan outer container 520B, a fluid containing sleeve 520A arranged in thecontainer 520B, and end seals. The fluid containing sleeve 520A containsall or nearly all of the fluid that is arranged in the container 520 andis in direct contact with a portion of the coating of the tube 514. Thefunnel and a distal portion of the tube 514 remains in a dry state in anon-fluid containing space of the package 512 a/512 b. Thus, only theportion of the catheter in contact with the sleeve 520A, i.e., a portionof the tube 514, is wetted or maintained in a pre-wetted state. Inembodiments, the sleeve 520 is non-removably coupled to the package 512a. In this way, the user can remove the catheter from the package andsleeve container 520 when the user grips the funnel and slides thecatheter out of the package. Since all or nearly all of the fluid whichhydrates the coating of the tube 514 is disposed in the sleeve 520A,removing the catheter will not cause any fluid to spill out of thepackage when opened, i.e., by removing the cap 512 b. Furthermore, asthe sleeve 520A remains in the container 520, the user need not comeinto contact with the fluid. Once the catheter is removed from thepackage with container 520, the user can move or slide the catheter backand forth and within the container 520 in order to sufficiently hydratethe coating of the tube 514. Once the coating is sufficiently hydrated,the user can remove the catheter by sliding it completely out of thecontainer 520. The user can then grip the funnel 517 and insert thecatheter into the user's body. Alternatively, the user can leave thecontainer 520 on while the catheter is advanced into the urethra. Inembodiments, the user can grip the sleeve 512 a and advance the catheterthrough the sleeve 512 a and into the urethra. As is the case withconventional catheters, the coating of the tube 514 is, in embodiments,a lubricious coating to facilitate insertion of the catheter into theuser's body.

In order to form the assembly package of FIG. 12, in embodiments, afluid containing sleeve 520A is hydrated and arranged in a containerbody 520B so as to form container 520. In this swollen state, the sleeve520A retains the fluid between an inside diameter and an outsidediameter. The container 520 can then be friction fit into the packagesleeve 512 a. The catheter is then slid into the container package 512 aby first inserting the distal end of the tube 514 into the container520. Furthermore, since the container 520B is fluid impermeable, itensures that the fluid in the sleeve 520A cannot escape the container520 or be contaminated with substances outside the package. Inembodiments, the inside diameter of the sleeve 520A is fluid permeableand wets and hydrates the coating of the tube 514 when contacting thetube 514. In embodiments, the outside diameter of the sleeve 520A isalso fluid permeable and slightly wets the container 520B whencontacting the same. However, unlike the coating of the tube 514, thecontainer body 520B does not absorb the fluid. In embodiments, theoutside diameter of sleeve 520A can alternatively be made fluidimpermeable so as not to wet the container body 520B when contacting thesame.

FIGS. 13 and 14 show another non-limiting embodiment of a pre-wettedurinary catheter of the present invention. FIG. 13 shows the catheterassembly package in a storage position and/or prior to useconfiguration. FIG. 14 shows the catheter assembly package in a positionjust prior to use.

The assembly package 610 shown in FIG. 13 includes a catheter arrangedwithin a first compartment 613 a of a flexible container 612 which canbe in the form of a package such as the type shown in FIG. 2. A fluidcontaining sleeve 620 is arranged within a second compartment 613 b ofthe container 612. The catheter has an insertable elongate tube portion614, one or more drainage eyelets, a funnel 617 arranged on a proximalend, and a distal end. The fluid containing sleeve 620 is sized to bepositioned over a substantial portion of the tube 614. When the userdesires to use the catheter, the user manipulates the package 610 sothat the catheter can be inserted into the sleeve 620 (see FIG. 14).Then, he can remove sealing cover 621 and remove the catheter from thecompartment 613 a. However, before the catheter is removed from thepackage 612, the tube 614 must be fully inserted into the sleeve 620 fora short predetermined time period (and retained in the configurationshown in FIG. 14), i.e., a few seconds to a few minutes (a time periodsufficient to allow the coating of the tube 614 to become sufficientlyhydrated and/or pre-wetted). As with the previous embodiment, the sleeve620 contains all or nearly all of the fluid that is arranged in thecontainer 612 and can be placed in direct contact with a coating of thetube 614. The funnel 617 and tube 614 remains in a dry state in anon-fluid containing space 613 a of the package 612. Thus, catheter isnot maintained in a pre-wetted state until it assumes the position shownin FIG. 14. In embodiments, the sleeve 620 is not removable from thepackage 612 with the catheter. Once removed from the package 612, theuser can grip the funnel 617 with one hand and the package 612 with theother hand, and then slide the catheter out of the compartment 613 a.Since all or nearly all of the fluid which hydrates the coating of thetube 614 is disposed in the sleeve 620, removing the catheter assemblyfrom the package 612 will not cause any fluid to spill out of thepackage 612 when opened. Furthermore, if the sleeve 620 is gripped fromoutside the package 612 and is retained in the compartment 613 b, theuser need not come into contact with the fluid. Once the catheter isproperly hydrated while in the package 612, it can be removed therefromand inserted into the user's body while the user grips the funnel 617,and, optionally the sleeve or package. As is the case with conventionalcatheters, the coating of the tube 614 is, in embodiments, a lubriciouscoating to facilitate insertion of the catheter into the user's body.

In order to form the assembly package of FIG. 13, in embodiments, asleeve 620 of the type shown in FIG. 5 can be inserted into compartment613 b shown in FIG. 13, then a catheter of the type shown in FIG. 7 canbe inserted into compartment 613 a shown in FIG. 13 and then the cap 621can be installed. However, prior to insertion into the package 612, thesleeve 620 can be exposed to or immersed in a fluid such as water. Sincethe sleeve 620 is made of a material that can absorb fluid and expand,this causes the sleeve 620 to swell until it reaches a wall thickness T(similar to that shown in FIG. 6). In this swollen state, the sleeve 620retains the fluid between an inside diameter and an outside diameter.Once the catheter is slid into the sleeve 620 (as shown in FIG. 14), itcan hydrate the coating of the tube 614. Furthermore, since the package612 is fluid impermeable, it ensures that the fluid in the sleeve 620cannot escape the package 612 or be contaminated with substances outsidethe package 612. In embodiments, the inside diameter of the sleeve 620is fluid permeable and wets and hydrates the coating of the tube 614when contacting the tube 614. In embodiments, the outside diameter ofthe sleeve 620 is also fluid permeable and slightly wets the package 612when contacting the same. However, unlike the coating of the tube 614,the package 612 does not absorb the fluid. In embodiments, the outsidediameter can alternatively be made fluid impermeable so as not to wetthe package 612 when contacting the same.

In each of the herein disclosed embodiments, the fluid containing memberor sleeve may, in embodiments, be a hydrogel sleeve. In embodiments, thefluid containing member may also have at least one of the following: awall thickness T that is 1/16 inch or greater, e.g., ⅛ inch, (in a fullyhydrated condition); may be generally cylindrical; may also bestructured and arranged to maintain a coating of the elongate member ina hydrated condition; may be a tube having an inside diameter sized toreceive therein the elongate member; may comprise an extrudedpolyurethane tube; may comprise D6/40 polyurethane; may comprise ahydrophilic polymer; may comprise at least one of: polyethylene oxide;poly vinyl alcohol; carboxy methyl cellulose; hydroxyl ethylmethacrylate; acrylic polymers; and collagen; may comprise a materialwhich swells when exposed to a fluid and which absorbs and retains fluidin a wall between an inner diameter and an outer diameter; may bestructured and arranged to swell when exposed to a fluid; may bestructured and arranged to swell when exposed to water; may bestructured and arranged to absorb about 90% of its weight in fluid; maybe structured and arranged to absorb about 90% of its weight in water;and may comprise a hydrated polyurethane tube.

The catheter insertion tube member and hydrating sleeve may have a roundcross-sectional shape, an oval cross-sectional shape, or any othercross-sectional shape that may facilitate insertion into the body of auser/patient, and, in particular, into the bladder of the user/patientthrough the urethra. The catheter insertion member in accordance withvarious embodiments) can preferably contain a biocompatible hydrophiliclubricious and/or antimicrobial coating on at least an outer surfacethereof. The coating may also have antimicrobial properties and/orcontain antimicrobial agents. Suitable non-limiting examples of suchlubricious and antimicrobial coatings are disclosed in U.S. Pat. Nos.4,585,666; 5,558,900; 5,077,352; 5,179,174; 6,329,488 (suitable for,e.g., polysiloxane substrates); 6,716,895; 6,949,598; and 7,179,849, andWO 2007/050685, each of which is incorporated by reference in itsentirety.

The antimicrobial agent used on the catheter may be one listed in anover the counter (OTC) monograph. Biocompatible coatings conform withthe following tests: mucosal irritation, sensitization, cytotoxicity,acute systemic toxicity, and implantation. (“Tripartite BiocompatibilityGuidance for Medical Devices,” DSMA (Apr. 24, 1987) (Updated May 21,1996)). The purpose of the wetting fluid is to maintain hydration of thelubricious coating such that upon insertion of the conduit into a user,at least an outer portion thereof is extremely slippery, facilitatinginsertion.

The catheter insertion member may preferably be constructed from asuitable polymeric material, such as such as polyvinyl chloride (PVC),silicone, latex or synthetic rubber. The components of the catheterdisclosed herein can also be made from various well-known materials. Forexample, the portions of the assembly other than the catheter insertionmember can be made of polyvinyl propylene, polyvinyl chloride,polyethylene, polypropylene and other types of suitable polymericmaterials. The components can be molded or extruded according towell-known manufacturing techniques.

Materials commonly used to make the catheter insertion member include,but are not limited to natural rubber latexes (available, for example,from Guthrie, Inc., Tucson, Ariz.; Firestone, Inc., Akron, Ohio; andCentrotrade USA, Virginia Beach, Va.), silicones (available, forexample, from GE Silicones, Waterford, N.Y., Wacker Silicones, Adrian,Mich.; and Dow Corning, Inc., Midland, Mich.), polyvinyl chlorides(available, for example, from Kaneka Corp., Inc., New York, N.Y.),polyurethanes (available, for example, from Bayer, Inc., Toronto,Ontario, Rohm & Haas Company, Philadelphia, Pa.; and Ortec, Inc.,Greenville, S.C.), plastisols (available, for example, from G SIndustries, Bassett, Va.), polyvinyl acetate, (available, for examplefrom Acetex Corp., Vancouver, British Columbia) polyacrylates(available, for example, from Rohm and Haas, Philadelphia, Pa.) andmethacrylate copolymers (available, for example, from Heveatex, Inc.,Fall River, Mass.). Synthetic and natural rubber latexes, polyurethanes,and silicones are preferred materials. Any combination of the foregoingmaterials may also be used in making catheters such as are used toproduce latex Foley catheters.

The urinary catheter, and in particular, the insertion member thereof,of the present invention can be manufactured by a variety of well-knownmethods. The tubing can be extruded and the funnel injection molded andthen attached to the desired length of tubing. The tip of the tube canthen be closed and rounded by thermoforming (for example, for PVC tubes)or molded (for example, for silicone tubes). Eye holes can then bepunched or otherwise formed near the tip of the distal end of the tubeto provide an outlet for urine drainage thru the tube when it isinserted into a bladder. Alternatively, the entire catheter can befabricated by dip molding. In this procedure, an elongated rod or “form”is dipped into a liquid coating material such as synthetic or naturalrubber latex, for example, to form a layer of material on the form. Thedeposition of material can be increased by first dipping the form into acoagulant solution to coat the form with a film of chemical that causesthe latex to coagulate onto the form. Calcium nitrate is commonly usedas the coagulant, and other additives may be used to enhance the removalof the tube from the form once the catheter is formed and dried. Theform has the shape and dimensions of the lumen of the catheter. Thecatheter may be formed from a single dip coating of the form or bymultiple coating layers. When a suitable material thickness is achievedon a form, the forms are dried to produce the catheter. If multiplecoatings are used to form the catheter, each coating may be dried beforethe next is applied. Once dried, the catheter may be stripped from theform. The catheters may then be washed and dried, and eyelets may thenbe formed thereon. Further manufacturing steps may be found in U.S.2004/0133156, the disclosure of which is incorporated by referenceherein.

The catheter insertion member may preferably be in the range of about 8cm to about 18 cm, and, it may have an elliptical cross-sectional shapesimilar to the shape of the male urethra. Different lengths, sizes(e.g., diameter, width, etc.), and configurations are possible for thecatheter, depending on the user's anatomy. For female users, theinsertable length may range from 40 to 100 mm, for example 50 to 80 mm,such as 55 to 75 mm. For male users, the insertable length can rangefrom 170 to 260 mm, such as 190 to 240 mm, for example 230 mm. The tipdesign can vary according to the needs of a user, for example, thecatheters disclosed herein can be provided with a coude tip. Thecatheter may have a round or substantially round cross-sectional shape,an oval cross-sectional shape, or any other cross-sectional shape thatmay facilitate insertion into the body of a user/patient, and inparticular, into the bladder of the user/patient through the urethra.According to various embodiments, the shape of the catheter can also bevariable along its length.

This invention has been described and specific examples of the inventionhave been portrayed. While the invention has been described in terms ofparticular variations and illustrative figures, those of ordinary skillin the art will recognize that the invention is not limited to thevariations of figures described. In addition, where methods and stepsdescribed above indicate certain events occurring in certain order,those of ordinary skill in the art will recognize that the ordering ofcertain steps may be modified and that such modifications are inaccordance with the variations of the invention. Additionally, certainof the steps may be performed concurrently in a parallel process whenpossible, as well as performed sequentially as described above.Therefore, to the extent there are variations of the invention, whichare within the spirit of the disclosure or equivalent to the inventionsfound in the claims, it is the intent that this patent will cover thosevariations as well. Finally, all publications and patent applicationscited in this specification are herein incorporated by reference intheir entirety as if each individual publication or patent applicationwere specifically and individually put forth herein.

What is claimed:
 1. A packaged catheter assembly, comprising: a fluidimpermeable container containing a fluid; a catheter positioned in thefluid impermeable container, the catheter including one or more drainageopenings in a distal portion of a catheter tube, and a funnel extendingfrom a proximal end of the catheter tube, the catheter tube including acoating on an outer surface of the catheter tube along a coated length;and a fluid containing sleeve positioned in the fluid impermeablecontainer, the fluid containing sleeve: having a length that issubstantially equal to the coated length of the catheter tube, includinga fluid-absorbing material containing all or nearly all the fluid of thefluid impermeable container, and configured to maintain the coating ofthe catheter tube in a hydrated condition while the funnel is maintainedin a dry state in the fluid impermeable container.
 2. The packagedcatheter assembly of claim 1, wherein the fluid containing sleevecomprises a hydrogel.
 3. The packaged catheter assembly of claim 1,wherein the fluid containing sleeve is cylindrical.
 4. The packagedcatheter assembly of claim 1, wherein the fluid containing sleeve isnon-removably coupled to an inside diameter of the fluid impermeablecontainer such that the fluid containing sleeve remains with the fluidimpermeable container when the catheter is removed from the fluidimpermeable container.
 5. The packaged catheter assembly of claim 1,wherein the fluid containing sleeve comprises an extruded polyurethanetube.
 6. The packaged catheter assembly of claim 1, wherein the fluidcontaining sleeve comprises a polyether polyurethane-urea.
 7. Thepackaged catheter assembly of claim 1, wherein the fluid containingsleeve comprises a hydrophilic polymer.
 8. The packaged catheterassembly of claim 7, wherein the hydrophilic polymer comprises at leastone of: polyethylene oxide; poly vinyl alcohol; carboxy methylcellulose; hydroxyl ethyl cellulose; hydroxyl ethyl methacrylate;acrylic polymers; and collagen.
 9. The packaged catheter assembly ofclaim 1, wherein the fluid containing sleeve retains the fluid betweenan inner wall and an outer wall of the fluid containing sleeve.
 10. Thepackaged catheter assembly of claim 1, wherein the catheter is in afirst compartment and the fluid containing sleeve is in a secondcompartment separate from the first compartment in the fluid impermeablecontainer.
 11. The packaged catheter assembly of claim 10, wherein thefirst compartment and the second compartment are fluid impermeable. 12.The packaged catheter assembly of claim 10, wherein the fluidimpermeable container includes a first removable cover configured toallow the catheter to be removed from the first compartment and a secondremovable cover configured to allow the catheter tube to be insertedinto the fluid containing sleeve in the second compartment.
 13. Thepackaged catheter assembly of claim 1, wherein the fluid containingsleeve includes 90% of its weight in absorbed water.
 14. The packagedcatheter assembly of claim 1, wherein the fluid containing sleeveincludes a fluid impermeable outer surface and a fluid permeable innersurface.
 15. The packaged catheter assembly of claim 1, wherein thefluid containing sleeve comprises a hydrated polyurethane tube.
 16. Thepackaged catheter assembly of claim 1, wherein the coating is selectedfrom the group consisting of a hydratable coating, a lubricious coating,and a hydrophilic biocompatible coating.
 17. The packaged catheterassembly of claim 1, wherein the packaged catheter assembly is anintermittent catheter assembly.
 18. The packaged catheter assembly ofclaim 1, wherein the fluid containing sleeve is positioned over asubstantial portion of the catheter tube in a single compartment of thefluid impermeable container.
 19. The packaged catheter assembly of claim1, wherein only portions of the catheter tube in contact with the fluidcontaining sleeve are maintained in the hydrated condition.
 20. Thepackaged catheter assembly of claim 1, wherein the coating includes anantimicrobial agent.